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‘No Simple Formula’: US FDA Decisions On Surrogate Endpoints Are Complex, Case-Specific

 
• By Sue Sutter

Office of New Drugs’ Peter Stein runs down the types of evidence and other considerations weighed in determining that a surrogate is reasonably likely to predict clinical benefit; however, some panelists at a National Academies meeting say the agency needs to increase transparency around its thinking on surrogates that can support accelerated approval.

Math formulas
The FDA has no simple formula for determining whether a surrogate endpoint is reasonably likely to predict clinical benefit. • Source: Shutterstock

US FDA Office of New Drugs director Peter Stein attempted to explain at a recent National Academies meeting on accelerated approval how the agency determines that a surrogate endpoint has been deemed reasonably likely to predict clinical benefit.

Nevertheless, non-FDA panelists said the agency needs to do more to make its thinking on surrogate endpoints in general, and...

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